Picc-Nate
A Single-Lumen Silicone Peripherally Inserted Central Catheter (Long Hub), Full Procedure Tray with Peel-Away Introducer, 1.9 French, without Iodine / Alcohol Swabsticks
5manufacturers in China registered for this device type
24catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Utah Medical Products, Inc., United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K001874 |
| Record published | 2016-09-23 |
| Record revised | 2021-02-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
| Sizes | Catheter gauge 1.1 to 3 Fr; catheter length 23 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Catheter | Catheter Gauge 1.9 Fr | In distribution |
| Catheter | Catheter Gauge 1.9 Fr | In distribution |
| Complete | Introducer Length – 25 mm | In distribution |
| Basic | Introducer Length – 35 mm | In distribution |
| Complete | Introducer Length – 35 mm | In distribution |
| Complete | Introducer Length – 35 mm | In distribution |
| Complete | Introducer Length – 35 mm | In distribution |
| Basic | Introducer Length – 35 mm | In distribution |
| Basic | Catheter Length 23 cm | In distribution |
| Catheter | Catheter Gauge 1.9 Fr | In distribution |
| Basic | Introducer Length – 35 mm | In distribution |
| Basic | Introducer Length – 25 mm | In distribution |
| Introducer | Introducer Length – 25 mm | In distribution |
| Basic | Introducer Length – 25 mm | In distribution |
| Complete | Introducer Length – 35 mm | In distribution |
| Repair Kit | Catheter Gauge 3 Fr | In distribution |
| Complete | Introducer Length – 25 mm | In distribution |
| Complete | Introducer Length – 25 mm | In distribution |
| Basic | Introducer Length – 25 mm | In distribution |
| Repair Kit | Catheter Gauge 1.9 Fr | In distribution |
| Complete | Introducer Length – 25 mm | In distribution |
| Complete | Introducer Length – 25 mm | In distribution |
| Introducer | Introducer Length – 25 mm | In distribution |
| Introducer | Introducer Length – 35 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K001874 | 2000-09-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.